Post by Admin/ Traveler on May 15, 2019 21:48:43 GMT
So, you already know that I have serious doubts about this new 'seasonal' vaccine (seasonal?? LOL - read on, please!). Here is the write up about it from the University that is creating it/working on it:
Preventive shot for Lyme disease, developed at UMass Medical School, moving forward
UMass Medical School Communications
May 03, 2019
"A seasonal shot to prevent Lyme disease, developed at UMass Medical School, is moving closer to clinical trial, thanks in part to a $1 million appropriation from the Massachusetts state budget, according to a May 2 briefing at the State House by Mark Klempner, MD, executive vice chancellor for MassBiologics of UMMS and professor of medicine.
“It’s really been a spreading, rising tide of cases that are concerning,” said Dr. Klempner of the increase in Lyme disease, noting that 35,000 to 40,000 annual cases reported nationwide are just a fraction of the actual figure, given how many cases go unreported.
Klempner explained that researchers at MassBiologics have identified a specific human monoclonal antibody that defends against Lyme disease. Unlike a vaccine, the new Lyme PrEP, a pre-exposure prophylaxis, uses a protein that specifically targets and blocks the Lyme-causing bacteria in the tick after it bites an inoculated host. UMMS is seeking $800,000 in the fiscal 2020 state budget to add to $2.1 million in school funds to allow Klempner’s team to test the safety and stability of the treatment, draft and file a new drug application with the Food and Drug Administration, and begin to conduct the first human trial.
Learn more in the media coverage, below:
(1)Worcester Telegram & Gazette: Antibody shows promise in fight against Lyme disease in UMass Medical Research
(2)Boston 25 News: Antibody shows promise in fight against Lyme disease
(3)WCVB/TV 5: Massachusetts researchers antibody work shows promise in fight against Lyme disease
(4)WWLP-22 News: Massachusetts researchers making progress in finding cure for Lyme disease
So, in reading one of those "learn more" articles (they each contain the same basic information), this is what I've discovered, since there's so little information given on the University's article:
In link(1) above: "“It’s really based on some very simple notion that the bacteria, before it comes to you, is stuck in the gut of the tick” and must make a complex trip through the tick before it can infect a human, he said Thursday at a briefing. “Our approach is to take advantage of this very complicated pathway for the bacteria to get out of the tick and into you ... a medicine that will circulate in you that when the tick drinks it, the blood will contain something that will kill the bacteria in the midgut or for sure prevent it from getting out of the gut so that none of this can happen.”"
So, first it's a simply "notion", then it's "very complicated"? Well, make up your mind!!! We already KNOW that Lyme disease is one of THE most complex infections at this time in medical history. So, to say that it's a "simple notion" that the bacteria is in the midgut isn't so simple really. It would be so very nice if they would just be honest with us, right?
But - there's more: "The team ran an initial test on mice in which the mice were injected with the antibodies and then exposed to six Lyme-infected ticks each. At a dose as low as 5 mg per 2.5 pounds of body weight, the mice were found to be 100 percent protected from Lyme disease, Klempner said. The team also tested the preventative treatment on a monkey and was able to protect the monkey from Lyme disease exposure."
So - they were able to protect a few animals with this - wonderful! That's a great first step - but there's more still:
"The development hit a snag, Klempner said, when his team realized that a single injection of antibodies would not protect a human for the duration of tick season.
“Our problem is that we’ve invented a drug that will be there for only a few weeks and yet your time of risk of exposure is many months, typically we say seven to eight months in our area around here,” he said.
Researchers found a way to modify the antibody treatment and extend its usefulness by up to three-and-a-half times in mice, he said, but have not yet been able to test on humans to find out how long the antibodies would sustain in a human body."
Well, that seems to be a pretty big snag!! Just how many preventative shots would we need then each year?
But, we aren't done yet:
"That’s where a new state investment would come in, according to UMass Medical School Vice Chancellor for Government Relations John Erwin. The school is seeking $800,000 in the fiscal 2020 budget, he said, which along with more than $2.1 million from the school would help Klempner’s team test the safety and stability of its treatment, draft and file a new drug application with the Food and Drug Administration, and begin to conduct the first human trial.
Klempner said he is hoping to get FDA approval to conduct modified studies for the second and third phases of the treatment’s development, which would be cheaper and possibly get the treatment to market sooner. The second phase study, he said, would typically cost up to $50 million but could be done for closer to $5 million if the FDA approves the modified test plan.
“If not, I’m going to have to partner with big pharma. It’s that simple,” Klempner said. In the most optimistic scenario, he said, the treatment could be available in about three-and-a-half years.
If or when the treatment becomes commercially available, the state could expect to recoup its investment. Under the terms of the funding, Klempner and Erwin said MassBiologics is required to make the treatment available to Massachusetts residents at a low cost and to pay back the state funding."
Follow the money!!!
And, just what would those "modified studies for the second and third phases of the treatment's development" really mean? HOW would they be modified - so much so that it's not actually PROVEN to work, like the last Lyme 'vaccine'?
Preventive shot for Lyme disease, developed at UMass Medical School, moving forward
UMass Medical School Communications
May 03, 2019
"A seasonal shot to prevent Lyme disease, developed at UMass Medical School, is moving closer to clinical trial, thanks in part to a $1 million appropriation from the Massachusetts state budget, according to a May 2 briefing at the State House by Mark Klempner, MD, executive vice chancellor for MassBiologics of UMMS and professor of medicine.
“It’s really been a spreading, rising tide of cases that are concerning,” said Dr. Klempner of the increase in Lyme disease, noting that 35,000 to 40,000 annual cases reported nationwide are just a fraction of the actual figure, given how many cases go unreported.
Klempner explained that researchers at MassBiologics have identified a specific human monoclonal antibody that defends against Lyme disease. Unlike a vaccine, the new Lyme PrEP, a pre-exposure prophylaxis, uses a protein that specifically targets and blocks the Lyme-causing bacteria in the tick after it bites an inoculated host. UMMS is seeking $800,000 in the fiscal 2020 state budget to add to $2.1 million in school funds to allow Klempner’s team to test the safety and stability of the treatment, draft and file a new drug application with the Food and Drug Administration, and begin to conduct the first human trial.
Learn more in the media coverage, below:
(1)Worcester Telegram & Gazette: Antibody shows promise in fight against Lyme disease in UMass Medical Research
(2)Boston 25 News: Antibody shows promise in fight against Lyme disease
(3)WCVB/TV 5: Massachusetts researchers antibody work shows promise in fight against Lyme disease
(4)WWLP-22 News: Massachusetts researchers making progress in finding cure for Lyme disease
So, in reading one of those "learn more" articles (they each contain the same basic information), this is what I've discovered, since there's so little information given on the University's article:
In link(1) above: "“It’s really based on some very simple notion that the bacteria, before it comes to you, is stuck in the gut of the tick” and must make a complex trip through the tick before it can infect a human, he said Thursday at a briefing. “Our approach is to take advantage of this very complicated pathway for the bacteria to get out of the tick and into you ... a medicine that will circulate in you that when the tick drinks it, the blood will contain something that will kill the bacteria in the midgut or for sure prevent it from getting out of the gut so that none of this can happen.”"
So, first it's a simply "notion", then it's "very complicated"? Well, make up your mind!!! We already KNOW that Lyme disease is one of THE most complex infections at this time in medical history. So, to say that it's a "simple notion" that the bacteria is in the midgut isn't so simple really. It would be so very nice if they would just be honest with us, right?
But - there's more: "The team ran an initial test on mice in which the mice were injected with the antibodies and then exposed to six Lyme-infected ticks each. At a dose as low as 5 mg per 2.5 pounds of body weight, the mice were found to be 100 percent protected from Lyme disease, Klempner said. The team also tested the preventative treatment on a monkey and was able to protect the monkey from Lyme disease exposure."
So - they were able to protect a few animals with this - wonderful! That's a great first step - but there's more still:
"The development hit a snag, Klempner said, when his team realized that a single injection of antibodies would not protect a human for the duration of tick season.
“Our problem is that we’ve invented a drug that will be there for only a few weeks and yet your time of risk of exposure is many months, typically we say seven to eight months in our area around here,” he said.
Researchers found a way to modify the antibody treatment and extend its usefulness by up to three-and-a-half times in mice, he said, but have not yet been able to test on humans to find out how long the antibodies would sustain in a human body."
Well, that seems to be a pretty big snag!! Just how many preventative shots would we need then each year?
But, we aren't done yet:
"That’s where a new state investment would come in, according to UMass Medical School Vice Chancellor for Government Relations John Erwin. The school is seeking $800,000 in the fiscal 2020 budget, he said, which along with more than $2.1 million from the school would help Klempner’s team test the safety and stability of its treatment, draft and file a new drug application with the Food and Drug Administration, and begin to conduct the first human trial.
Klempner said he is hoping to get FDA approval to conduct modified studies for the second and third phases of the treatment’s development, which would be cheaper and possibly get the treatment to market sooner. The second phase study, he said, would typically cost up to $50 million but could be done for closer to $5 million if the FDA approves the modified test plan.
“If not, I’m going to have to partner with big pharma. It’s that simple,” Klempner said. In the most optimistic scenario, he said, the treatment could be available in about three-and-a-half years.
If or when the treatment becomes commercially available, the state could expect to recoup its investment. Under the terms of the funding, Klempner and Erwin said MassBiologics is required to make the treatment available to Massachusetts residents at a low cost and to pay back the state funding."
Follow the money!!!
And, just what would those "modified studies for the second and third phases of the treatment's development" really mean? HOW would they be modified - so much so that it's not actually PROVEN to work, like the last Lyme 'vaccine'?